# K233247: Heuron ICH

- Pathway: 510(k) (Traditional)
- Applicant: Heuron Co., Ltd.
- Decided: May 15, 2024 after 230 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN170073 (2018). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221240: BriefCase, Aidoc Medical, Ltd. (2022) Summary page 4.

## Indications for use
Heuron ICH is radiological computer-aided triage and notification software designed for the analysis of non-contrast head CT images in adults or transitional adolescents aged 18 and older. This device is intended to aid appropriately trained medical specialists and hospital networks in streamlining workflow by identifying and communicating suspected positive findings of Intracranial hemorrhage (ICH). Heuron ICH employs an artificial intelligence algorithm to analyze non-contrast CT images, flagging cases with identified findings through a dedicated application that operates in parallel with the standard of care image interpretation process. Users receive notifications for cases with suspected findings, which include compressed preview images provided for informational purposes only and are not intended for diagnostic use beyond notification. Importantly, Heuron ICH does not modify the original medical images and is not intended to serve as a diagnostic device. The results generated by Heuron ICH are intended to complement other patient information and assist medical specialists in prioritizing and triaging medical images. Notified medical specialists are responsible for viewing the full non-contrast CT images in accordance with established standard of care practices.

Source page: https://510kreport.com/device/K233247
Methodology: https://510kreport.com/methodology